Senior Biostatistics Consultant

1 week ago


Mumbai Nagpur, India beBeeBiostatistician Full time

Statistical Analysis Expert

Job Summary:

This role involves supporting statistical tasks throughout the lifecycle of clinical trials, from protocol development to Clinical Study Report (CSR). The successful candidate will prepare Statistical Analysis Plans (SAPs), develop tables, listings, and figures (TLFs), and provide biostatistical support for clinical trials.

Key Responsibilities:
  • Provide comprehensive statistical support across all phases of a project, from protocol development to CSR.
  • Prepare SAPs and create mock-up displays for TLFs.
  • Collaborate with sponsors and internal teams to ensure high-quality deliverables and regulatory compliance.
  • Independently review project work produced by other biostatisticians.
  • Develop programming specifications for analysis datasets, TLFs, and other outputs.
  • Review SAS annotated case report forms (CRFs), database designs, and study documentation for completeness and protocol compliance.
  • Verify and quality control project deliverables to ensure consistency with SAP and specifications.
  • Represent biostatistics on project teams and contribute to internal meetings and discussions.
  • Manage multiple projects, timelines, and priorities, proactively communicating challenges to management.
  • Identify out-of-scope tasks and escalate to management as needed.
  • Provide statistical programming support and participate in Data Safety Monitoring Boards (DSMB) or Data Monitoring Committees (DMC).
  • Lead integrated analyses projects and respond to sponsor queries.
  • Adhere to SOPs, Work Instructions (WIs), and relevant regulatory guidelines.
  • Maintain organized, complete, and up-to-date project documentation and verification/quality control programs.
  • Support business development activities by contributing to proposals and bid defense meetings.
  • Coach and mentor junior Biostatistics staff.
Qualifications:
  • Graduate degree in Biostatistics or related field.
  • Moderate experience in clinical trials or equivalent combination of education and experience.
  • Proficiency in statistical programming (e.g., SAS).
  • Knowledge of statistical design, analysis, regulatory guidelines, and programming techniques in clinical research.
  • Experience across all statistical tasks required to support clinical trials during the project lifecycle.
  • Excellent written and verbal communication skills; ability to read, write, speak, and understand English.


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